FDA approved low-dose estrogen

The FDA has approved a 10-mcg low-dose formulation of estradiol vaginal tablets for the treatment of atrophic vaginitis due to menopause.

This approval makes the new formulation (Vagifem, Novo Nordisk) the lowest local estrogen therapy dose commercially available in the United States, according to a statement by Novo Nordisk.

A 25-mcg tablet was approved for use in 1988 in Europe and 1999 in the United States.

Approval of the 10-mcg dose was based on the results of a 52-week, randomized, placebo-controlled, multicenter trial. Data indicated statistically significant improvements with the estradiol vaginal tablets vs. placebo in symptoms of atrophic vaginitis, including vaginal dryness, vaginal or vulvar irritation/itching, vaginal soreness and painful urination and intercourse. It was also associated with corrections in vaginal pH and vaginal maturation index.

One year of continuous treatment with the low-dose estrogen was also safe and well tolerated by women.

Adverse events were similar between treatment and placebo groups; most were mild to moderate. The most common adverse events were vulvovaginal mycotic infection, back pain and vulvovaginal pruritus.

Atrophic vaginitis is directly related to the loss of estrogen associated with menopause.

The estradiol vaginal tablets deliver estrogen directly to the vagina via an easy-to-use applicator. The tablet is expected to be available in pharmacies in the first quarter of 2010.